Background of the study
Over the 80% of patients undergoing pancreatic surgery for adenocarcinoma, then experience disease recurrence mainly in terms of distant metastases. The adoption of the standard adjuvant treatment, the monotherapy gemcitabine, allows to slightly reduce the risk of relapse. More recently, a French study has shown a better efficacy and activities of a more intensive scheme, called FOLFIRINOX, including the association of three cytotoxic drugs (5-fluorouracil, oxaliplatin and irinotecan), compared to conventional gemcitabine as first-line treatment for patients with metastatic disease. A treatment regimen including the same chemotherapy drug, administered in a different schedule, was developed by GONO group in metastatic colorectal cancer, with better safety results, especially in terms of hematologic toxicity, when compared with FOLFIRINOX.
Aim of the study
Our study aims to compare the efficacy of FOLFOXIRI and gemcitabine in patients with radically resected pancreatic cancer, in terms of disease-free survival, overall survival and safety profile.